Teen’s effort on home hemodialysis machine may help invigorate market with few choices

A story in September detailed the work of Anya Pogharian on a new portable hemodialysis machine. The 18-year-old from Montreal is collaborating with Héma-Québec, which manages the blood supply of Quebec, to test the machine, which she built for $500 for a science fair, CBC News Montreal reported.

Pogharian told CBC that she was inspired to create the device after volunteering at a hospital dialysis unit.

She hoped the machine would filter four liters of blood in two and half hours, but initial tests showed it took only 25 minutes. The device has not yet been tested on humans, but Pogharian told CBC that she hopes it will be useful in disaster zones and developing countries. She told CBC News that she is working nonstop on the project. “To date, I have been working crazy hours on this project … I’ve stopped counting,” she said. And she expects her machine to hit the market in a couple of years.

That may be wishful thinking. As CEO Jeff Burbank and his staff know at NxStage Medical, the road to device approval and the capital to build a new dialysis machine can be overwhelming—particularly for a small company with a single product.

Where is the industry’s R&D efforts on building home hemodialysis machines?

It took more than eight years for the U.S. Food and Drug Administration to approve NxStage’s request to designate nocturnal dialysis as a modality option for its SystemOne machine.

The Lawrence, Mass.-based company is working on a new home hemodialysis machine that can also be used in-center, as well as a peritoneal dialysis machine, and a critical care system. But the rest of the dialysis manufacturing industry has been slow to develop new products to encourage more dialysis at home.

Baxter Healthcare has close to 90% of the U.S. peritoneal dialysis market and has a new cycler machine on the way. But recent problems with shortages of the dialysate needed to perform CCPD has stunted expansion and growth in the U.S. More competition would offer alternatives.

NxStage Medical, like Baxter in peritoneal, has the lion’s share of the home hemodialysis market. Baxter and Fresenius have talked about new home dialysis machines, and Baxter trotted out its Vivia home hemodialysis machine last year for the first time at the Annual Dialysis Conference. The machine has been approved for the European market, but no indication when clinical trials will be complete and when the machine will be available here.

When Fresenius bought Renal Solutions Inc. in November 2007—almost 10 years ago—for $190 million, many thought that the dialysis products manufacturer would take the sorbent technology developed by RSI and build a new home hemodialysis machine to replace Fresenius’ 2008K machine.

RSI was working toward commercializing the Allient Sorbent Hemodialysis System for home use when they were acquired by Fresenius. The sorbent technology purifies tap water to dialysate quality and allows dialysate to be regenerated. “The combination of Fresenius Medical Care’s leading hemodialysis technology and the SORB technology will provide a platform for superior home products and therapies. Furthermore, the significant reduction of dialysate through SORB technology is one major step towards miniaturization – a pre-requisite for the wearable kidney concept which could benefit certain patients and complement clinical-based therapy,” Fresenius said at the time.

Neither a new home hemodialysis machine, nor a wearable kidney for that matter, has hit the market.

Outset Medical’s Tablo dialysis system

Perhaps the closest we are to seeing a new home hemodialysis dialysis machine is the Tablo. Already FDA approved for acute and in-center settings, the Tablo will make its manufacturing debut in the first half of 2016, according to its developer, San Francisco-based Outset Medical. The company says it is aiming the machine for in-center use initially, preferably for use in self-care settings. Eventually, those patients could move with the Tablo to a home environment.

Tablo offers several technologies: real-time, on-demand purified dialysate production; direct wireless data transmission; and an automated approach to setting up and completing a treatment, the company says. “By liberating dialysis from expensive infrastructure, Tablo may usher in new technology-driven service models that could significantly reduce cost and profoundly change the patient care experience.” Average set up time is 15 minutes; average take down time is 5-10 minutes, the company claims.

Let’s hope the Tablo invigorates innovation in the home therapy market. If there is a belief that the U.S. patient census for home dialysis should go beyond 10-12%, having ample therapy options is helpful.

Good on her. Unfortunately, as the article points out, the expense of a dialysis machine isn’t in its parts or overall design. It is in the expense of creating, testing and certifying a device that could easily cause death in the event of an error. Also, the fixed cost of a dialysis machine is relatively minor compared to the cost of supplies (dialysate, artificial kidneys, needles, tubes, meds, delivery, disposal, …) and personnel (technicians, nurses, doctors).

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